NCT03530449

Evaluation of the Repeatability and Reproducibility of OCTA Image Quality With the Heidelberg Engineering SPECTRALIS With OCT Angiography Module

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 39 (actual)
• Sponsor: Heidelberg Engineering GmbH · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

Repeatability and Reproducibility of OCTA Image Quality with the Heidelberg Engineering SPECTRALIS

Detailed description

The objectives of this study are to: 1. Assess the repeatability and reproducibility of the SPECTRALIS with OCTA Module image quality 2. Assess the repeatability and reproducibility of visibility of key anatomical vascular structures in the SPECTRALIS with OCTA Module

Conditions

• Retinal Vascular
• Normal Eyes

Interventions

Type	Name	Description
DEVICE	OCT Angiography	OCT Angiography offers clinicians a non-invasive three-dimensional visualization of vasculature in the retina and choroid. The visualization of perfused vasculature in a three-dimensional layout, offers clinicians an aid in the identification of retinal and choroidal pathologies such as retinal ischemia, microaneurysms, retinal neovascularization and choroidal neovascular membranes.
DEVICE	Color Fundus Photography	Non-contact white light photography
DEVICE	Optical Coherence Tomography	Two and Three dimensional cross sectional imaging of the back of the eye to look at vascular structures and is an aid in the detection and management of various ocular diseases.

Timeline

• Start date: 2018-04-30
• Primary completion: 2018-09-15
• Completion: 2018-09-15
• First posted: 2018-05-21
• Last updated: 2019-02-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study